Assessing fallopian tubal patency

ABSTRACT

A method of assessing Fallopian tubal patency includes introducing a distension medium into a patient&#39;s uterus, introducing a contrasting medium into the uterus, and observing the contrasting medium, for example, via a hysteroscope, to determine whether the contrasting medium flows into one or both Fallopian tubes. A device for assessing Fallopian tubal patency includes a chamber for receiving contrast media, a flow path through the chamber for delivering distension media to a patient&#39;s uterus, and a flow controller for regulating the flow of distension media to the patient&#39;s uterus. The flow path is configured to permit flow of contrast media from the chamber into the flow path.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/100,302, filed Nov. 20, 2020, now allowed, which is a continuation ofU.S. application Ser. No. 16/248,444, filed Jan. 15, 2019, now U.S. Pat.No. 10,842,363, issued Nov. 24, 2020, which is a continuation of U.S.application Ser. No. 15/267,388, filed Sep. 16, 2016, now U.S. Pat. No.10,456,019, issued Oct. 29, 2019, which claims the benefit of U.S.Provisional Application Ser. No. 62/220,444, filed Sep. 18, 2015. All ofthese prior applications are incorporated by reference in theirentirety.

This disclosure relates to methods and devices for hysteroscopicallyassessing Fallopian tubal patency.

BACKGROUND

Several methods of tubal patency assessment have been previously used.These include hysterosalpingogram, chromopertubation, chlamydia antibodytesting, and sonosalpingography. In a hysterosalpingogram, an X-ray dyestudy of the Fallopian tubes is performed.

Chromopertubation is performed during laparotomy or laparoscopy, both ofwhich are abdominal surgeries. Chlamydia antibody testing is a bloodtest reflecting risk for tubal disease from previous chlamydiainfection. Sonosalpingography is an approach that uses ultrasound toobserve infusion through a transcervical catheter of a combination ofair bubbles in saline or other combinations of fluids with or withoutair to evaluate the Fallopian tubes. Hysteroscopy has also been used toadvance a catheter into the Fallopian tube, with infusion of dye throughthe catheter. A hysteroscope can also been introduced into the uterusand then after removal of the hysteroscope be followed by ultrasound tosee if fluid accumulated in the pelvis during the hysteroscopy withoutdirectly observing the process of air or fluid entering or traversingthe Fallopian tubes. Falloposcopy has also been used where a cameraenters the Fallopian tubes.

SUMMARY

Fallopian tubal patency is assessed by adding air to saline duringhysteroscopy. A hysteroscope is advanced past the uterine cervix to lookinside the uterus while saline expands the uterine cavity. Air isintroduced into the saline and the contrast between the saline and theair allows for visualization as to whether the air bubbles are enteringthe Fallopian tube, indicating that the Fallopian tube is open, or areremaining in the uterine cavity, indicating that the air bubbles are notable to enter the Fallopian tube. The inability of air bubbles to entera Fallopian tube can be due to, for example, a closure in the Fallopiantube, a temporary spasm in the Fallopian tube, or other damage to theFallopian tube. In addition, microscopic patency can exist even if airbubbles are not able to enter the Fallopian tube.

A method of assessing Fallopian tubal patency includes introducing amedium, for example, 0.9% normal saline, into a patient's uterus todistend the uterus; introducing a contrasting medium, for example, airor water insoluble oil, into the distended uterus; and observing thecontrasting medium, for example, via a hysteroscope, to determinewhether the contrasting medium flows into one or both Fallopian tubes.The method may include introducing the distension medium and/or thecontrasting medium via the hysteroscope.

For this technique, in which a camera is advanced past the cervix toobserve whether contrasting substances (such as saline and air) passfrom the uterus into the Fallopian tubes, syringes, inversion of thedrip chamber in IV tubing, and other approaches can be used forintroducing contrasting substances. However, because introduction ofcontrasting substances with one hand can be difficult (as the other handis holding the hysteroscope), this introduction is often done by anassistant. A device designed to be held and operated by one hand hastubing passing through the device that can be connected with IV tubingand a hysteroscope. The tubing in the device is associated with a flowrate regulator that affects the speed with which substances, for example0.9% saline, can pass through the tubing. Over a portion of the tubinginternal to the device, the tubing is porous so that an additionalsubstance (or substances), for example air, can be introduced into thetubing. The internal chamber (or reservoir) where the additionalsubstance or substances can be introduced into the porous tubing isconnected to the outside of the device via a conduit. Substances, forexample, air or a water insoluble oil, can be added through this conduitif the contrasting substance is not initially present when the device ismade. The use of a water insoluble oil has advantages in instances wherethere is a need for the contrast medium to sink in saline, for example,for a backward tipped uterus.

A device for assessing Fallopian tubal patency includes a chamber forreceiving contrast media; a flow path through the chamber for deliveringdistension media to a patient's uterus; and a flow controller forregulating the flow of distension media to the patient's uterus. Theflow path, for example, tubing passing through the chamber, isconfigured to permit flow of contrast media from the chamber into theflow path.

Embodiments of this aspect may include one or more of the followingfeatures. The tubing is perforated to permit flow of contrast media fromthe chamber into the tubing. The flow controller is an adjustable clamp.The adjustable clamp is hand controlled. The chamber is configured to beheld in an operator's hand. The flow controller is configured to beoperated by the same hand holding the chamber for one-handed operation.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates a hysteroscopy set-up;

FIGS. 2 and 2A illustrate a technique of assessing Fallopian tubalpatency including the introduction of a contrasting medium into adistension medium of the hysteroscopy set-up;

FIG. 3 illustrates the passage of contrasting medium through openFallopian tubes;

FIG. 4 illustrates contrasting medium blocked from passage due to closedFallopian tubes;

FIG. 5 is a top view of a device for facilitating hysteroscopicassessment of Fallopian tubal patency;

FIGS. 6-6D are side views of the device illustrating a flow regulatingclamp of the device;

FIGS. 7 and 7A illustrate the introduction of contrast medium into thedistension medium;

FIGS. 8 and 8A are side views of a dual chamber embodiment of thedevice; and

FIG. 9 illustrates a single chamber embodiment of the device.

DETAILED DESCRIPTION

A flexible hysteroscope, for example, a 2.5 mm flexible pediatrichysteroscope available from Karl Storz (Model 11262BCU1), is used forbubble introduction and visualization. Prior to hysteroscopy,transvaginal ultrasound including antral follicle count can beperformed. Tenacula and local anesthesia are typically unnecessary.

The Parryscope technique for hysteroscopic assessment of Fallopian tubalpatency is performed using a hysteroscopy setup. For example, referringto FIG. 1 , a hysteroscopy setup includes a hysteroscope 10 coupled to asource of distention medium 12, for example, 0.9% normal saline, via IVtubing 14 and a drip chamber 16. The hysteroscope 10 includes a lightsource cord 18 and a video cord 20. In use, a speculum 22 is placed in awomen's vagina 24 and the hysteroscope 10 is passed through the speculum22 and the women's cervix 26 into the uterus 28. The typical visiblerange of the hysteroscope 10 is illustrated by dashed line 30 andincludes the entrances to the Fallopian tubes 32.

As illustrated in FIG. 2 , after the end 34 of the hysteroscope 10 isadvanced past the cervix 26, the operator introduces an appropriatedistention medium 12 for hysteroscopy through the hysteroscope into thepatient's uterus 28 to distend the uterus, filling the uterus andFallopian tubes 32 with distension medium 12. If the Fallopian tubes areoccluded at their end distal to the uterus, the Fallopian tubes may fillwith fluid, but if the tubes are occluded proximal to the uterus, theymay not fill with fluid. As the uterus and ostia (the connection betweenthe Fallopian tube and the uterus) are visualized, an amount of air,typically 0.25 milliliters per infusion and preferably less than 2milliliters for the entire procedure, is then introduced into the uterusby dispersing air bubbles 36 in the IV tubing 14 (FIG. 2A). The airbubbles can be introduced into the IV tubing 14 by, for example,inversion of the drip chamber 16 or syringe injection into the IV tubing14. The operator then observes, via the hysteroscope, whether theresulting air bubbles flow into one or both Fallopian tubes (FIG. 3 ) orthrough neither where the tubes are missing or present but occluded(FIG. 4 ) to assess whether the Fallopian tubes are open. Air bubblesenter the Fallopian tubes and pass through the Fallopian tubes into thepelvis. Of note, with adequate time to equilibrate for the initialsaline infusion, it is unlikely for air bubbles to enter an occludedtube due to the lack of a gradient driving flow through.

An alternative contrasting substance can be used, including one withgreater density than saline, which would sink rather than rise. This hasvalue for the retroflexed uterus which “tips backwards.”

Prior to introducing the hysteroscope, the operator will typically firstplace a speculum to visualize the cervix and clean the cervix. Though avaginoscopic approach can be done, where the hysteroscope is placed inthe vagina without a speculum, speculum use allows for the assessment ofvaginal disease that might otherwise be harder to visualize. The salineflow rate of the hysteroscope is adjusted for the anticipated cervicaldilation and whether the Fallopian tubes are believed open or closed.The more closed the cervix and the more closed the Fallopian tubes, theslower the rate of flow should be. When advancing the hysteroscopethrough the cervix, the hysteroscope is adjusted for the naturalcontours on the cervix, and is advanced until the uterine cavity isvisualized. If the uterus is poorly distended, the rate of salineinfusion may be increased. If the uterus is over distended or thepatient is uncomfortable, the rate may be decreased. The uterine cavityis inspected for pathology.

Air bubbles are then introduced, for example, by inversion of the dripchamber on the IV tubing. Typically ¼ of a milliliter of air is all thatis required, which translates to an approximately 4 cm column instandard IV tubing. Alternatively, air bubbles can be introduced througha syringe port in the tubing or other approaches. The air bubbles can beflicked in the tubing to create multiple small bubbles instead of onelarge bubble, but if doing this, a single tiny bubble entering the tubalostia should not be deemed demonstrative of patency in case the distaltubal fimbria are closed. If air bubbles preferentially congregatetowards one side, the patient's hips should be rolled so that thecontralateral side is now elevated, causing air bubbles to rise to thatside. Additional columns of air bubbles may be added if needed, but twoto three columns of air bubbles are typically sufficient and the needfor more than six should be rare. If not passing into the tubes, the airbubbles should be observed, such as for 30 to 60 seconds, next to theostia to exclude the possibility of tubal spasm. After completeassessment of the uterine cavity and evaluation of the bilateral ostia,the hysteroscope is removed, as is the speculum.

The method for assessing patency may exhibit one or more of thefollowing advantages. The technique is gentle with minimal patientdiscomfort; can be done with low cost for disposable equipment; can beperformed in the physician's office; is easy for physicians to learn;uses saline and air, which are unlikely to cause allergic reactions; anddoes not use X-rays.

The technique can be performed on an awake patient. This enables thepatient to deliberately rotate her hips to one side or another, whichcan help air bubbles reach the ostia (where the Fallopian tubes connectwith the uterus), which is important if the position of the uterus makesit hard for air bubbles to reach a particular side. Alternatively, thetable can be tilted for an asleep patient. The patient's bladder ispreferably completely empty or partially empty to favor air bubblesrising towards her tubal ostia when lying on her back. However, otherpositions can be used, including but not limited to having a patientwith a retroflexed uterus lying on her front.

The technique uses a 2.5 mm or smaller flexible hysteroscope forvaginally nulliparous patients. Though varying sizes can be used,preferably the hysteroscope is smaller than the diameter of the innercervical lumen to minimize dilation or stretching of the cervix. Forpatients that have had a previous vaginal delivery, a largerhysteroscope may be appropriate, so as to increase the rate of salineinflow and reduce the rate of saline outflow around the hysteroscope.Although the technique can be performed with a rigid hysteroscope, it ispreferred to use a flexible hysteroscope to reduce trauma to the cervixby allowing for easier adjustment to natural contour, as well as toadjust for the anteflexion normal to most uteri with an empty bladder.Fiberoptic, charge-coupled device, and a variety of other types ofendoscopic cameras can be used.

The 0.9% normal saline preferred for the method is the same as patientsreceive intravenously in numerous medical settings and the small amountsused (typically less than 250 mL, some of which will egress through thecervix and not be absorbed) during the procedure are unlikely to causeproblems. However, other fluids (for example, Hyskon, glycine, mannitol,and others) could be used. Though air emboli travelling to the lungs areunlikely, the amount of air introduced is less than that typical tosonosalpingography or echocardiograms, which are accepted interventionswith rare complications from air infusion. As an alternative to air,other solutions that can be distinguished from the distention media canbe used, and multiple permutations involving differing weight,solubility, and color can allow for seeing the contrasting substancepass in to the Fallopian tubes. IV tubing or hanging bags of distentionmedia are not mandatory, as there are multiple other ways of introducingfluid and air, such as by having syringes directly attached to thehysteroscope.

Gases, such as air, are also potential distention medium, with the useof liquids as the contrasting medium. For example, if the uterus istipped backwards, gas would fill the uterus, and the liquid would enterthe Fallopian tubes because the heavier liquid would sink.

Referring to FIG. 5 , a flow regulator 50 for controlling the flow ofdistension medium 12 and the introduction of bubbles into the distensionmedium can be connected between the distention medium 12, with orwithout intervening tubing 14, and the hysteroscope 10. Alternatively,the regulator 50 can be built into the hysteroscope or into a containerwith the distention medium. Adapters 52, such as Luer or Christmas treeconnections, facilitate attachment. The flow regulator 50 is sized andconfigured to be held in the operator's hand 54, with the operator'sthumb 56 and fingers 58 illustrated in FIG. 5 . Ergonomic contouring canbe present or absent.

Referring to FIG. 6 , the flow regulator 50 includes a clamp 60 throughwhich tubing 14 passes, a chamber 62 for holding contrast medium, forexample, air, through which tubing 14 also passes, and a channel 64 forthe addition of contrast medium to the chamber 62. The distention medium12 passes through the regulator 50 through the tubing 14. The size ofthe lumen of the tubing 14 can be selected to provide desired pressureand infusion rate within the uterus, as appropriate for hysteroscopy.Though different flow regulation devices can be used with the flowregulator 50, the flow regulator clamp 60 illustrated in FIGS. 6-6Dincludes a wheel 66, which is rolled upwards or downwards with variabledegrees of tubing compression so as to determine the speed through whichthe distention medium passes through the flow regulator 50. The clamp 60is shown in the closed position in FIGS. 6A and 6B and in the fully openposition in FIGS. 6C and 6D. Alternatives to the clamp 60 include a flowregulator valve or a design in which the walls of the chamber 62 act toregulate flow through the tubing 14 by restricting the tubing 14 as thetubing passes through the walls, the restriction of the tubing 14 beingalleviated by pressure exerted on the chamber by the operator squeezingthe chamber, allowing for increased flow.

The contrasting medium chamber 62 surrounds a portion of the tubing 14.The chamber 62 can be incorporated in various ways into the flowregulator 50, such as before or after the flow regulator clamp 60, andthe chamber 62 can have a volume of, for example, about 10-50 mL.Porousness of the tubing 14 within the chamber 62 allows the addition ofthe contrasting medium into the tubing 14 so that the contrasting mediumis present with the distention medium. The tubing diameter and lumensize and the number of sites for porousness can be varied. For example,if saline is the distention medium and air is the contrasting medium,depending on the porousness selected, the regulator 50 would generate afew large air bubbles or many small air bubbles.

As illustrated in FIGS. 7 and 7A, the porous tubing 14 located withinthe chamber 62 can define channels 70 that allow entry of contrastmedium when opened through pressure. To force the contrasting mediuminto the tubing 14, in one example, the operator squeezes the flowregulator 50, arrow 72, increasing the pressure in the chamber 62,pushing the contrasting medium across the porous region of the tubing 14into the tubing 14. The combined distention and contrast medium thenadvance briefly through the tubing 14 before releasing pressure.

The release of pressure in the embodiment of FIG. 7 draws distentionmedium in the reverse direction into the contrast medium chamber 62.Referring to FIGS. 8 and 8A, to avoid mixing of the mediums within thechamber 62, a unidirectional porous tubing can be used, which allowscontrast medium to enter the tubing 14 with pressure, with displacementof distention medium into a separate chamber with release of pressure.The contrasting medium chamber 62 includes two separate chambers 80 a,80 b. The portion of tubing 14 in the first chamber 80 a allows contrastmedium to enter the tubing from the chamber 80 a when pressure isapplied to the chamber 62 (FIG. 8 ), and the portion of tubing 14 in thesecond chamber 80 b allows contrast medium to exit the tubing into thechamber 80 b when pressure is released (FIG. 8A).

FIG. 9 illustrates a flow regulator 50 for assisting in hysteroscopicassessment of Fallopian tubal patency having a single contrast mediumchamber 62 and a clamp 60 external to the chamber 62. The clamp 60 canbe located upstream or downstream of the chamber 62, though bypositioning the clamp 60 downstream of the chamber 62, squeezing thechamber so that contrasting medium enters the tubing 14 does not have asignificant effect on the pressure experienced by the patient. Chamber62 can be constructed, for example, of silicone, and, in the illustratedembodiment has a volume of 150 mL for contrast medium, though smaller orlarger volumes can be used. For example, the chamber 62 can be aSilicone Evacuator available from Medline Industries, Inc., Ref #DYNME1305. The tubing 14 for flow of distension medium can beconstructed of, for example, silicone having, for example, an innerdiameter (lumen) of about 3.2 mm and an outer diameter of about 6.4 mm,a porosity of one millimeter with six points of fenestration, and can bestraight or include a loop or loops inside the chamber 62. The loop orloops increases the length of the tubing within the chamber to spreadout the porosity, increasing the spacing between air bubbles within thedistension medium.

What is claimed is:
 1. A method of assessing Fallopian tubal patency,comprising: introducing a distension medium into a patient's uterus todistend the uterus; introducing a contrasting medium into the distendeduterus; and observing the contrasting medium via a hysteroscope todetermine whether the contrasting medium flows into a Fallopian tubes.2. The method of claim 1 wherein introducing the distension mediumcomprises introducing the distension medium via the hysteroscope.
 3. Themethod of claim 1 wherein introducing a contrasting medium comprisesintroducing the contrasting medium via the hysteroscope.
 4. The methodof claim 1 wherein the distension medium comprises saline.
 5. The methodof claim 1 wherein the contrasting medium comprises air.
 6. The methodof claim 1 wherein the contrasting medium comprises water insoluble oil.7. A device for assessing Fallopian tubal patency, comprising: a chamberfor receiving contrast media; a flow path through the chamber fordelivering distension media to a patient's uterus; and a flow controllerfor regulating the flow of distension media to the patient's uterus;wherein the flow path is configured to permit flow of contrast mediafrom the chamber into the flow path.
 8. The device of claim 7 whereinthe flow path comprising tubing passing through the chamber.
 9. Thedevice of claim 8 wherein the tubing is perforated to permit flow ofcontrast media from the chamber into the tubing.
 10. The device of claim7 wherein the flow controller comprising an adjustable clamp.
 11. Thedevice of claim 10 wherein the adjustable clamp is hand controlled. 12.The device of claim 7 wherein the chamber is configured to be held in anoperator's hand.
 13. The device of claim 12 wherein the flow controlleris configured to be operated by the same hand holding the chamber forone-handed operation.